Senior Clinical Trial Manager
October 17, 2019
Location: Buffalo Grove, IL
Classification – Full-time position
We are looking for self-motivated, creative problem solvers who are excited by the idea of working in a fast-paced start-up environment and contributing to our growth. Senior Clinical Trial Manager will be a key contributor within Development Operations and reports to the Head of Development Operations.
- Lead the execution of clinical studies for an assigned clinical study/studies, supporting clinical strategy defined in the Development Plan (DP).
- Manage highly complex clinical study/studies within a program.
- Responsible for the successful planning, implementation and execution of clinical study/studies in an assigned clinical study/program in compliance with quality standards (including ICH GCP, local regulations and Phathom SOPs), on schedule and within budget.
- Manage Clinical Research Organization and other vendors to meet Phathom’s obligations described in ICH-GCP and Phathom’s business objectives.
- Manage the overall execution of assigned clinical study/studies to meet drug development objective.
- Consistently deliver high-quality, on time, on budget, including making or recommending operational decisions (with input from Development Operations leadership) in support of achieving clinical program objectives.
- Responsible for managing study scope, critical path and budget.
- Work closely with Development Operational Leadership to ensure program objectives are met. Represent Development Operations for assigned study in issue escalation/awareness with Development Operations leadership.
- Responsible for operational execution for assigned clinical study/studies; serves as main point of contact for cross functional issues, including any CRO/ vendor performance issues.
- Responsible for clinical study/studies budget planning and accountable for external spend related to study execution. Works closely with Finance to ensure on a regular basis that budgets, enrollment, and forecasting are accurate. Communicates study status, cost and issues to ensure timely decision-making by Development Operations leadership.
- Manage vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to CRO/vendor for assigned program, including escalation of issues when warranted. Responsible for operational risk management strategy in collaboration with CRO and effectively communicate when deliverables are at risk.
- Provide study-level input in collaboration with the CRO for the development of study management plans including enrollment models and risk management plans, financial planning and management, communication and monitoring plans; system development participation including IRT and EDC.
- Participate in development of protocol, CRF, CSR and other key study team deliverables in collaboration with CRO.
- Provide operational input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents.
- Serve as a resource to facilitate audit or inspection readiness.
- Support operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling.
- Bachelor’s Degree required; Life Sciences preferred
- Minimum 4 years of applicable clinical operations experience
- Proven success in effectively managing external clinical research organizations/partners including vendors and investigators is required.
- Sound understanding of clinical trial regulations across regions.
- Knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP, including experience with global regulations and global regulatory inspections is required. Familiarity with industry interpretations to ensure compliance while reducing complexity is desired.
- Global/international experience desired
- Solid written and verbal presentation skills, including fluent business English skills (oral and written).
To apply for this opening, please submit your resume to email@example.com.